FDA reports detailing Essure complications now list a death
10:14 PM, Nov 7, 2013
5:36 AM, Nov 8, 2013
The Food and Drug Administration's publicly searchable database of adverse reaction reports now lists a death among the records for the
birth control device Essure. The FDA approved the device for use in 2002.
The device, which is made of up two coils implanted in a woman's fallopian tubes, has been the
topic of complaints by thousands of women in a Facebook group. The product, previously made by Conceptus and now sold by Bayer, has 943 adverse reaction reports listed on the FDA's website.
One of those reports lists a death for a patient in August 2013. The record, which does not list the patient's name or any identifying information about the event, was posted to the FDA site in September.
It says the patient had an Essure procedure. She went to an emergency room with abdominal pain at some point, although the report does provide details on the timeframe between when Essure was implanted and the patient's visit to the ER.
According to the report, a pelvic exam of the woman indicated her cervix, fallopian tubes and uterus were necrotic, and she tested positive for a form of strep. A physician cited in the report says he believes the cause of death was related to necrotizing Group A Streptococcus infection.
The report does not create a link between the procedure and the woman's death, with an attending physician saying "the cause of death was not directly related to the Essure inserts or procedure".
Bayer, which recently bought Conceptus, told our sister station KNXV it does not comment on individual adverse reaction cases. But the company told ABC2, "We take the safety of our products very seriously. We are saddened to hear of any serious health condition affecting a patient using one of our products, regardless of the cause."
Bayer's spokeswoman says the complaints made to the FDA reflect a small percentage of the more than 750,000 women who use the device worldwide.